Healthy Volunteers Clinical Trial
— DANA1Official title:
Neuroplasticity Induced by General Anaesthesia
Verified date | August 2021 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. In addition, to explore possible associations between neuroplastic changes and clinical and/or biochemical outcomes. It is a randomised, cross-over, single blinded clinical study. N = 30. Female:male ratio 1:1.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 13, 2021 |
Est. primary completion date | August 13, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Age =18 and =35. - Healthy individual. - BMI =18 kg/m2 and =30kg/m2. - Normal electrocardiogram (ECG). - Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse. - American Society of Anaesthesiologists (ASA) class 1. - Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details. - Right-handed. - Female participants must use safe contraceptives (hormonal or mechanical, including intrauterine devices). - Speaks and understand Danish. - Provides oral and written informed consent. Exclusion Criteria: - Contraindications to MRI. - Left-handedness or ambidexterity. - History of complications to general anaesthesia, including malignant hyperthermia. - Family history of malignant hyperthermia. - Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives. - Allergy to any kind of medication or material to which the volunteer could be exposed during this study. - History of serious illness. - History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness. - Major trauma or head trauma with any symptoms present at the time of inclusion. - Surgery less than six weeks prior to the study period. - Infection (with fever) less than two weeks prior to or during the study sessions. - Daily use of any medication (not counting contraceptives). - Consumed anti-depressants during the last 30 days before study days. - Weakly intake of >21 (for females >14) units of alcohol. - Heavy intake of caffeine (> 5 cups/day). - Smoking during the last 30 days before study days. - Substance abuse (assessed by the investigator). - Pregnancy - Reflux or dyspepsia. - Poor dental status or oral health. - Expected or suspected difficult airway. - Declines receiving information regarding accidental pathological findings during MRI scans of the brain. - Cannot cooperate to tests. - Otherwise judged unfit for participation by the investigator. Exclusion Criteria during the study: - Any of the above-mentioned exclusion criteria. - Major trauma or head trauma during the study period. - Surgery during the study period. - Infection (with fever) during the study period. - Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day) - Consumed analgesics within 3 days before each study day - Consumed anti-histamines less than 48 hours before each study day - Intake of caffeine 12 h prior to each study day - Smoking |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neuroanaesthesiology | Glostrup | Capital Region |
Denmark | Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup | Glostrup | Capital Region |
Lead Sponsor | Collaborator |
---|---|
Signe Sloth Madsen |
Denmark,
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* Note: There are 64 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in T1w3D | Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI. | 8 days | |
Primary | Changes in DTI | White matter microstructure as measured using Diffusion Tensor Imaging (DTI) | 8 days | |
Secondary | Changes in rsfMRI | Differences in resting state functional MRI induced by general anaesthesia | 8 days | |
Secondary | Changes in fatigue | Differences in severity and characteristics of fatigue related to general anaesthesia, as measured by Multidimensional Fatigue Inventory (MFI-20, a scale of 0-5 in each of 20 questions, with higher scores indicating more fatigue). | 8 days | |
Secondary | Cognitive performance | Changes in cognitive function related to general anaesthesia, measured with a combination of Test of Attentional Performance, Paced Auditory Serial Addition Test and Conners Continuous Performance Test. | 8 days |
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